EP0277678A1 - A graft suitable for treatment by reconstructive surgery and having tissue-specific porosity, and a process for making such graft - Google Patents

A graft suitable for treatment by reconstructive surgery and having tissue-specific porosity, and a process for making such graft Download PDF

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Publication number
EP0277678A1
EP0277678A1 EP88200076A EP88200076A EP0277678A1 EP 0277678 A1 EP0277678 A1 EP 0277678A1 EP 88200076 A EP88200076 A EP 88200076A EP 88200076 A EP88200076 A EP 88200076A EP 0277678 A1 EP0277678 A1 EP 0277678A1
Authority
EP
European Patent Office
Prior art keywords
graft
granular material
biodegradable
solvent
matrix
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP88200076A
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German (de)
English (en)
French (fr)
Inventor
Atze Jan Nijenhuis
Jan Willem Leenslag
Albertus Johannes Pennings
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Stichting Science Park Groningen
Original Assignee
Stichting Science Park Groningen
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Stichting Science Park Groningen filed Critical Stichting Science Park Groningen
Publication of EP0277678A1 publication Critical patent/EP0277678A1/en
Withdrawn legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30756—Cartilage endoprostheses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30965—Reinforcing the prosthesis by embedding particles or fibres during moulding or dipping
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones
    • A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/30004—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis
    • A61F2002/30011—Material related properties of the prosthesis or of a coating on the prosthesis the prosthesis being made from materials having different values of a given property at different locations within the same prosthesis differing in porosity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30062—(bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A61F2002/30084—Materials having a crystalline structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0004—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof bioabsorbable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0023—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in porosity

Definitions

  • This invention relates to a graft suitable for the treatment by reconstructive surgery of damaged cartilage tissue, bone tissue, vascular tissue and nerve-tissue.
  • vascularization and the ingrowth of the several cell types into the graft can be greatly influenced by the pore size and pore size distribution in the graft used.
  • a graft with a pore size of about 400 ⁇ m results in a rapid ingrowth of the connective tissue.
  • the pore size considered to be optimal for the formation of bony tissue is 150 to 250 ⁇ m.
  • Vascularization of a graft takes place especially when this graft contains pores of 10-60 ⁇ m.
  • a pore size of 25 to 150 ⁇ m is used, with the pore size increasing from the inside outwardly.
  • grafts An essential feature in all of the above grafts is the interconnectivity of the pores in three dimensions throughout the entire graft.
  • the grafts must have a controlled and reproducible pore size and pore size distribution.
  • a graft of the above kind characterized by a porous matrix of an organic polymeric material with a bi-porous structure.
  • the organic polymeric material of the porous matrix according to the invention is preferably bio­degradable.
  • the porous matrix according to the invention may be compounded with a biodegradable fibrous material and/or with a biodegradable first granular material.
  • a biodegradable organic polymeric matrix material for the graft use can be made of a polyurethane material, for example, a polyether urethane, a polyester urethane, a polyether urea urethane or a polyester urea urethane; a polylactide material, for example, a poly-L-lactide, a poly-D-lactide or a poly-DL-lactide; a polyglycolide material, for example, a polyglycol acid; a polylactone material, for example, a poly- ⁇ -valerolactone, a poly- ⁇ -caprolactone; a polyhydroxy-carboxylic acid material, for example, a poly- ⁇ -hydroxybutyric acid; a polyester material, for example, polytetramethylene adipate, polyethylene adipate, polyhexamethylene glutarate, polyethylene terephthalate; a hydroxy-carboxylic acid copoly
  • the pure L, D and DL stereoisomers of lactide can be used separately or as a mixture of these.
  • Separate polymeric materials can be used or mixtures thereof, possibly with still other biodegradable organic polymeric materials, for example, with a polyamide material.
  • the fibrous material for reinforcement and/or as a stimulus for tissue ingrowth can be incorporated in the matrix in the form of loose fibres, but also in the form of a woven or knitted fabric or other coherent combination of fibres and comprises fibrous material of a biodegradable organic polymeric material, for example, fibres of a polyurethane material, for example, a polyether urethane, polyester urethane, polyether urea urethane, a polyester urea urethane; a polylactide material, for example, a poly-L-lactide, a poly-D-lactide, a poly-DL-lactide; a polyglycolide material, for example, a polyglycolic acid; a polylactone material, for example, a poly- ⁇ -valerolactone, a poly- ⁇ -caprolactone; a poly-hy­droxycarboxylic acid material, for example, a poly- ⁇ -hy­ droxybutyric
  • the starting material may be the separate polymeric materials specified herein­before, or mixtures thereof. Fibres of a single fibre material can be used or mixtures of fibres of different fibre materials. The fibres used may be solid, porous or hollow.
  • the first granular material for reinforcement and/or as a stimulus for tissue ingrowth of the composite according to the invention can be incorporated in the matrix in the form of loose granules.
  • the granules to be used according to the invention are of a biodegradable, polymeric or non-polymeric, organic or inorganic material and comprise granules of the organic polymeric materials specified above or of inorganic salts, for example, tricalcium phosphate, calcium carbonate, calcium sulphate, magnesium phosphate.
  • Granules of a single granule material can be used or granules of different granule materials.
  • the granules used may be solid or porous.
  • the fibres and/or granules can be pre-treated.
  • This pre-treatment may comprise coating the fibres and/or granules with a suitable material or roughening and activating the fibre and/or granule surface by means of annealing.
  • additives can be incorporated to affect the biodegradability of the matrix and/or the biodegradability of the fibres and/or the biodegradability of the granulate.
  • these additives may consist of free carboxylic acids, amino acids or hydroxycarboxylic acids, for example, lactic acid, glycolic acid, citric acid, tartaric acid, glutaric acid, fumaric acid or salicylic acid.
  • additives incorporated in the graft may be growth factors, for example FGF, CGF, NGF (Fibroblast Growth Factor, Chondrocyte Growth Factor, Nerve Growth Factor, respectively), growth promoting and growth inhibiting agents, antibiotics, sedatives, vitamins, building materials and nutrients.
  • FGF FGF
  • CGF CGF
  • NGF Fibroblast Growth Factor, Chondrocyte Growth Factor, Nerve Growth Factor, respectively
  • growth promoting and growth inhibiting agents antibiotics, sedatives, vitamins, building materials and nutrients.
  • Each of these additives or each preferred combination may be incorporated in the matrix material and/or fibrous material and/or first granulate material. Depending on the additive to be used and the purpose thereof, it may also be distributed over the pore walls of the graft, for example, by steeping the graft with a solution of the additive, and drying it. Hollow fibres closed at both ends and filled with one or more additives or a suspension or solution thereof can also be used.
  • the invention also relates to a process for making the graft and is characterized by subjecting a solidified polymeric solution under reduced pressure to a sublimation process to remove the solvent, the solidified polymeric solution being composed of the polymeric material or mixture of polymeric materials constituting the porous matrix; a sublimable solvent or a mixture of sublimable solvents, or a mixture of one or more sublimable solvents and one or more sublimable first non-solvents; and a second granular material different from said first granular material and capable of being washed out with a solvent which is not a solvent for the biodegradable organic polymeric matrix, referred to herein as the second non-solvent.
  • the solidified polymeric solution is built up from a minimum of three components.
  • the first component consists of the polymer or the polymer mixture to form the matrix.
  • the second component consists of a solvent or a solvent mixture or a mixture of one or more solvents with one or more first non-solvents.
  • the third component comprises a second granular material which differs from said first granular material and comprises a ground, powdered or crystalline material having a pre-determinable particle size or particle size distribution.
  • This second granular material may be of organic nature, for example, sugars, such as saccharose and lactose or, for example, urea, or it may be of inorganic nature, for example, an inorganic salt, such as NaCl, NaF, Na2SO4, KBr, or it may a mixture of organic and inorganic materials.
  • the second granular material must be soluble in a solvent, the second non-solvent, which does not function as such for the polymeric matrix or, if used, the fibrous material and/or, if used, said first granulate.
  • the object of the second granular material is to give a portion of the graft the desired porosity by washing out this material.
  • a next component may be the above fibrous material and/or said first granular material and/or said
  • a characteristic feature of the grafts according to the present invention is a bi-porous structure. This means that the graft comprises different pore structures, each having its own pore size and pore size distribution.
  • This structure is formed as a result of the fact that the pores caused by the second granular material are interconnected by a porous matrix.
  • the relatively smaller pores in the matrix are caused by evaporating the polymer solvent or solvent mixture or a mixture of one or more solvents with one or more first non-solvents.
  • the second granular material may have any selected particle size and particle size distribution. When a second granular material is used with a narrow particle size distribution, for example, 200 ⁇ m ⁇ 10 ⁇ m, the pores formed by this material will be similar in size and size distribution.
  • the pores formed by this material will, in turn, have a similar size and size distribution.
  • the structure is referred to as a bi-porous structure.
  • a graft according to the invention combines pores with pore sizes at no fewer than two different size levels. Without wishing to be limited by the following theory, we suppose that in all probability this promotes the simultaneous ingrowth of specific tissues, although it is not excluded that one tissue type exhibits a much faster ingrowth than the other.
  • vascularization of the graft takes place by capillary blood vessels which substantially grow through the microporous matrix.
  • Car­tilaginous cells are formed in the large pores in a later stage.
  • the graft i.e., the nerve guide
  • the graft serves no other function than stimulating the growing together of the separated nerve cell parts.
  • the non-porous inside of the nerve guide is surrounded by a microporous outside. The ingrowth of surrounding tissue into the microporous outside provides for a good fixation of the nerve guide, whereby dislocation is prevented.
  • a very slowly biodegradable or non-biodegradable component may be incorporated in the graft.
  • the retention of mechanical or physical properties may also give rise to such measures.
  • the invention is illustrated in and by the following examples of producing a graft.
  • a commercial polyester urethane sold under the tradename of Estane 5701-Fl (Goodrich Co., Brechville, Ohio, USA) was used. Furthermore, a poly-L-lactide was used with an v of up to 6.105. From the poly-L-lactide, fibres were made by a well-known dry-spin-hot-stretch process. The poly-L-lactide used therefor had an ⁇ M v of 5-6 ⁇ 105. The elongation at break of the fibres was 0.5-1.2 GPa and the Young′s modulus was 6-15 GPa.
  • the poly-L-lactide used in the polymeric mixture had an v of 3.5.105.
  • Crystalline saccharose (Merck) was sieved, and the fraction with a particle size of 100 - 300 ⁇ m was used.
  • the Estane 5701 Fl was precipitated once by precipitation of a 5% w/w polymer solution in dimethyl formamide (DMF) (Merck "pro-analysis” quality) in a six-fold volume of ice water.
  • the precipitated polyurethane was washed once with 96% ethanol and once with diethyl ether, and was then dried overnight in a vacuum stoveat 40°C.
  • the poly-L-lactide fibres used were coated with Estane 5701-Fl by steeping them in a 5% w/w solution in tetra­hydrofurane (THF) (Merck "pro analysis” grade) of the polyurethane, whereafter the fibres were dried in a vacuum desiccator for 1 hour.
  • THF tetra­hydrofurane
  • the resulting disk with a height of about 1 cm and a diameter of about 4 cm, was dried at 0.005 mbar for 12 hours to remove the 1,4-dioxane.
  • the resulting porous sample was extracted with water for 24 hours to remove the sugar crystals.
  • a last extraction with 96% ethanol was effected for 24 hours to remove residues of 1,4-dioxane.
  • After drying the sponge was porous as to about 65% and contained 17% poly-L-lactide fibres. Pores with a size of 80-300 ⁇ m, formed by the sugar crystals used, turned out to be interconnected by channel-shaped pores with a diameter of about 10 ⁇ m, caused by the evaporation of the 1,4-dioxane.
  • Polyurethane and poly-L-lactide were used as in Example I.
  • the sample was kept at -15°C for 12 hours, where­after it was dried at 0.01 mbar for 12 hours. Thereafter the porous material was extracted with 96% ethanol for 24 hours to remove the last residues of trioxane and 1,4-dioxane. To remove the sodium chloride granules, it was subsequently extracted with water for 24 hours. After drying the sponge was porous as to about 70-75%. Pores with a size of 80-300 ⁇ m, formed by the salt crystals used, were found to be interconnected by pores with a size of 10-60 ⁇ m, formed by evaporating the solvent crystallized.
  • the size of the pores caused by the evaporation of the solvent could be greatly influenced by the ratio of trioxane : dioxane. When a 70% trioxane/30% dioxane mixture is used, these pores reach a size of 20-150 ⁇ m.
  • a mould can be used.
  • the solidified polymer solution, built up from the above components, is removed from the mould and then prepared further in accordance with the process.
  • grafts can also be made to size by hand or machining. If necessary the graft material may be cooled to improve its machinability.
  • one or more layers of a polymer solution, built up from the various components specified hereinbefore, can be applied to a tube or rod which, if necessary, is cooled.
  • the tube or rod with the solidified polymer solution thereon can then be prepared further in accordance with the process.
  • this solution may be varied in composition layer by layer, so that the porosity, biodegradability and physical properties can be controlled for each layer separately.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Rheumatology (AREA)
  • Materials For Medical Uses (AREA)
EP88200076A 1987-01-19 1988-01-18 A graft suitable for treatment by reconstructive surgery and having tissue-specific porosity, and a process for making such graft Withdrawn EP0277678A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
NL8700113A NL8700113A (nl) 1987-01-19 1987-01-19 Entstuk, geschikt voor behandeling door reconstructieve chirurgie, met weefsel specifieke porositeit, alsmede werkwijze ter vervaardiging van het entstuk.
NL8700113 1987-01-19

Publications (1)

Publication Number Publication Date
EP0277678A1 true EP0277678A1 (en) 1988-08-10

Family

ID=19849432

Family Applications (1)

Application Number Title Priority Date Filing Date
EP88200076A Withdrawn EP0277678A1 (en) 1987-01-19 1988-01-18 A graft suitable for treatment by reconstructive surgery and having tissue-specific porosity, and a process for making such graft

Country Status (7)

Country Link
EP (1) EP0277678A1 (da)
JP (1) JPS63272355A (da)
AU (1) AU1037688A (da)
DK (1) DK20988A (da)
FI (1) FI880147A (da)
NL (1) NL8700113A (da)
NO (1) NO880193L (da)

Cited By (81)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0324852A1 (en) * 1987-07-20 1989-07-26 Regen Biologics, Inc. Prosthetic meniscus
EP0359575A2 (en) * 1988-09-16 1990-03-21 Clemson University Soft tissue implant with micron-scale surface texture to optimize anchorage
FR2643555A1 (fr) * 1989-02-28 1990-08-31 Macgregor David Dispositif d'implant a surface poreuse pour chirurgie plastique
EP0399782A2 (en) * 1989-05-23 1990-11-28 Minnesota Mining And Manufacturing Company Modifying a membrane for use as a graft
EP0461201A1 (en) * 1989-03-02 1991-12-18 Regen Corp PROSTHETIC THREAT.
US5108438A (en) * 1989-03-02 1992-04-28 Regen Corporation Prosthetic intervertebral disc
WO1992006653A1 (de) * 1990-10-19 1992-04-30 Klaus Draenert Werkstoff und verfahren zu seiner herstellung
WO1992007525A1 (en) * 1990-10-31 1992-05-14 Baxter International Inc. Close vascularization implant material
US5116374A (en) * 1989-03-02 1992-05-26 Regen Corporation Prosthetic meniscus
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AU1037688A (en) 1988-07-21
FI880147A (fi) 1988-07-20
NL8700113A (nl) 1988-08-16
FI880147A0 (fi) 1988-01-14
JPS63272355A (ja) 1988-11-09
NO880193L (no) 1988-07-20
DK20988A (da) 1988-07-20
NO880193D0 (no) 1988-01-18
DK20988D0 (da) 1988-01-19

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